1. Field of the Invention
The present invention relates to a composition for processing bodyfluids, an apparatus for processing bodyfluids, a method of processing bodyfluids and to products made from bodyfluids. In another aspect, the present invention relates to a composition of enzyme inhibitors for processing blood and cerebrospinal fluid, to an apparatus made of enzyme inhibitors for processing blood and cerebrospinal fluid, to a method of processing cerebrospinal fluid and blood utilizing enzyme inhibitors, and to products made from cerebrospinal fluid or blood.
2. Brief Description of the Related Art
Biological bodyfluids, such as cerebrospinal fluid, blood, amniotic fluid, and other fluids, are routinely removed from humans and other animals and subjected to analytical testing. Such analytical testing is useful for diagnosing and treating diseases, conditions and other pathologies.
Since such analytical testing will be used for medical diagnosis and treatment, accurate test results are obviously very necessary and important. Unfortunately, once bodyfluids are drawn they can undergo degradative, catabolic, anabolic or other processes which may alter the outcome of the test results so that they are not reflective of actual body conditions. To ensure proper and accurate test results, it is important that the integrity of such bodyfluids be maintained so that the test results are reflective of actual body conditions.
Generally, to maintain the integrity of a bodyfluid sample, analytical testing is performed as soon after sampling as possible, or it is refrigerated or frozen with the test to be performed at a later time as soon after thawing as possible.
While it is most desirable to conduct analytical testing promptly after the bodyfluid is drawn, the practical reality is that analytical testing is not always performed as promptly as is desired. Additionally, with time consuming test procedures, the integrity of the bodyfluid can also be compromised during the testing procedure.
Another practical reality is that many physician's offices and smaller laboratories, lack the ability to conduct all but the most simple of analytical testing procedures, either because of the complexity of the analytical procedure and/or the cost of the necessary analytical equipment.
Thus, very commonly, bodyfluid samples are drawn at the physician's office or at smaller laboratories and then shipped frozen with dry ice to larger laboratories where the analytical procedures are performed.
Unfortunately, freezing the bodyfluid only creates a new set of problems in testing the fluid. For example, the sample must be promptly and properly frozen. With blood samples, this first requires centrifuging to remove the red blood cells prior to freezing. During this freezing process, time is of the essence to freeze the sample as promptly as possible. Next, the sample must be shipped with an adequate amount of dry ice to insure that it remains frozen. Once the sample arrives at the testing laboratory, care must be taken to carefully thaw the sample to ensure the integrity of the sample. Generally this requires thawing the sample slowly in an ice water bath. Finally, once the sample is thawed, time is once again of the essence, as the analytical tests must be performed promptly after thawing.
When testing is required to make a determination of, for example, myelin basic protein, parathyroid hormone, adrenocorticotrophic hormone, prostate specific antigen or alpha-fetoprotein, just to name a few, many physician's offices and small laboratories will draw the sample and ship it frozen to a larger laboratory with the ability to perform such desired analytical testing.
For example, U.S. Pat. No. 4,136,160, issued Jan. 23, 1979 to Cohen discloses an assay for active demyelinization. Many diseases and pathologies of the human body are associated with the destruction of myelin, a lipoprotein-rich membrane that surrounds, protects and is critical to neuronal function of the central nervous system. One of the degradation products of demyelinization is a protein known as myelin basic protein. This protein accounts for as much as thirty percent of the protein found in myelin and may be its major structural protein.
One of the major demyelinating diseases suffered by man is multiple sclerosis. In multiple sclerosis, patches of destroyed myelin are replaced by scar tissue that interrupts and distorts the flow of nerve impulses.
The Cohen '160 patent discloses a radioimmunological assay ("RIA") for the detection and measurement of myelin basic protein in cerebrospinal fluid to provide a means for the diagnosing and evaluating the clinical progress of multiple sclerosis and other demyelinating pathologies. It is very clearly taught in Cohen '160 that the cerebrospinal fluid must be tested immediately or stored frozen until assay.
To prevent clotting, either ethylenediamine tetraacetic acid or citric acid salts, both metalo-peptidase inhibitors, are sometimes added to blood.
As the foregoing illustrates, there is a need in the art for a method of processing bodyfluids that will allow for longer time periods between the drawing of the bodyfluid and the analytical testing of such bodyfluids.
This is also a need in the art for a method of processing bodyfluids that will allow for longer time periods in the freezing and thawing of samples to be frozen.
These and other needs will become apparent to those of skill in the art by the following description of the invention.
Thus, it is an object of the present invention to provide a composition useful in the processing of bodyfluids and in the analytical testing of bodyfluids.
It is another object of the present invention to provide a method of processing bodyfluids and of testing bodyfluids.
It is yet another object of the present invention to provide an apparatus useful in the processing and analytical testing of bodyfluids.
It is still yet another object of the present invention to provide for products made from bodyfluids.
It is even still yet another object of the present invention to provide an improved method of analyzing bodyfluids for adrenocorticotrophic hormone, alkaline phosphatase isoenzymes, alpha-fetoprotein, atrial natriuretic factor, c-reactive protein, calcitonin, carbohydrate antigen 19-9, carcinoembryonic antigen, cerebrospinal fluid IgG index, ceruloplasmin, follicle stimulating hormone, gastrin, interleukins, myelin basic protein, parathyroid hormone, parathyroid-related hormone, prolactin, prostate-specific antigen, protein c antigen, ristocetin co-factor plasma, ristocetin inhibitor assay screen, thyroid stimulating hormone, or vasoactive intestinal polypeptide.
These objects and other objects of the present invention will become more apparent to those of skill in the art by the following description of the invention.